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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00994903
Other study ID # StatCol
Secondary ID
Status Completed
Phase Phase 3
First received October 13, 2009
Last updated November 27, 2013
Start date October 2011
Est. completion date September 2013

Study information

Verified date November 2013
Source University of Auckland, New Zealand
Contact n/a
Is FDA regulated No
Health authority New Zealand: Health and Disability Ethics Committees
Study type Interventional

Clinical Trial Summary

Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs that have an established role in the medical management of cardiovascular disease. Their benefits have also been shown in the surgical setting with decreased cardiovascular complications and lower perioperative mortality following cardiac and vascular surgery. There is now considerable evidence showing statins have useful pleiotropic properties that extend beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating the proinflammatory and metabolic stress response to surgery and the benefit of statins may extend to other surgical settings such as abdominal surgery.

Laboratory studies demonstrate the surgically-relevant benefits of statins and show they decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion injury, improve survival in models of abdominal sepsis, decrease the formation of postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses. Retrospective clinical studies show statins improve outcomes in sepsis, reduce the postoperative systemic inflammatory response syndrome (SIRS) and are associated with decreased rates of surgical wound infections and postoperative respiratory complications following various non-cardiac general surgical procedures. However, no prospective studies have specifically evaluated the perioperative use of statins in abdominal surgery. Using colorectal surgery as a model for major abdominal surgery, the investigators will conduct a randomised controlled trial evaluating the effect of perioperative statin use on postoperative morbidity, local and systemic inflammatory response, and functional recovery after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion criteria:

- Consecutive consenting patients undergoing elective colectomy, rectal resection, and reversal of Hartmann's procedure at Middlemore Hospital, Manukau Surgery Centre, Auckland City Hospital, and North Shore Hospital.

Exclusion criteria:

- Acute presentation

- Already taking statins or other lipid-lowering medication

- Known adverse reaction to statins

- Hepatic dysfunction

- Moderate to severe renal dysfunction

- Previous history of rhabdomyolysis

- On contraindicated medication

- Pregnancy

- Breastfeeding

- Patient choice.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Simvastatin
40mg orally, given 3-7 days pre-op and continued till 14 days post-op
Placebo
Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)

Locations

Country Name City State
New Zealand Auckland City Hospital Auckland
New Zealand Manukau Surgical Centre, Middlemore Hospital Auckland
New Zealand North Shore Hospital Auckland

Sponsors (4)

Lead Sponsor Collaborator
University of Auckland, New Zealand Auckland District Health Board, Counties Manukau Health, Waitemata District Health Board

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total complications Complications pre-defined and graded by the Clavien-Dindo classification Up to post-operative day 30 No
Secondary Peritoneal Cytokines Postoperative Day 1 No
Secondary Serum cytokines Post-operative Day 1 No
Secondary Change in serum C-reactive protein (CRP) Baseline and Postoperative Day 1, 2 and 3 No
Secondary Change in functional recovery Baseline and Postoperative Day 1, 3, 7, 14, and 30 No
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